MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8300.23G02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This incident has occurred during surgery.Insufficient infusion in the line post prime but surgeon changed the set and continued with same issue.Insufficient infusion may lead to imbalance in the internal pressure of the eye since there was no error code shown to identify the issue.Hence this complaint is concluded as reportable.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
An email was received from the sales rep who sent us a defective vgpc tubing set.On 27mar2017 further information has been received.The product identified in this incident is article #8300.23g02, lot 2000381723 and had been primed and surgery was ready to start.There was no error code or alert; however it was noticed insufficient infusion flow post prime.This set was taken down and was set up again on a different machine with same issue noted.Therefore it is likely the incident was caused by this set.No patient injury and sample was saved for evaluation.

• Brand Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7669950
• Report Number: 1222074-2018-00234
• Device Sequence Number: 789572
• Product Code: HQE
• UDI-Device Identifier: 08717872019000
• UDI-Public: 08717872019000
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 8300.23G02
• Device Lot Number: 2000381723
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1